What is the purpose of this trial?
Protocol 13VR3 is is a multi-center, open-label study assessing long-term somavaratan administration.
Patients will be monitored for safety throughout their participation in the study. Safety will be monitored by physical examination, inspection of injection sites, vital signs, clinical laboratory determinations (including fasting glucose, insulin, and lipids), 12-lead ECGs (for new treatment naïve subjects and subjects not previously exposed to somavaratan), PK/PD assessments, and immunogenicity assessments.
Adverse events (AEs) and concomitant medications will be captured. AEs will be coded using CTCAE v 4.0. AEs will be coded using the MedDRA dictionary and CMs using the WHO Drug dictionary.
Ages: 3 years and older
Dates: 01/19/2017 - 03/31/2018
Last Updated: 05/24/2017
Study HIC#: 1610018569